Support the development and execution of upstream bioprocess capabilities within the Biologics Research organization, supporting a pipeline of biotherapeutic programs from early discovery through preclinical CMC.
Compensation
$103,000.00-131,000.00 Annual
Responsibilities
Perform hands-on experiments in upstream processing (USP): Microbial (e.g., E. coli) and mammalian (e.g., CHO, HEK) expression systems, including cell culture maintenance, media preparation, and bioreactor operation at bench scale
Assist in the setup, maintenance, and operation of research bioprocess development laboratories
Write and follow experimental protocols and standard operating procedures (SOPs)
Compile and summarize experimental data into electronic laboratory notebook entries, presentations, and technical reports
Collaborate with Discovery, Analytical, Technical Operations, and Preclinical Development teams
Assist in the development of chromatography, electrophoresis, spectroscopy and mass spectrometry-based analytical methods to support product release, stability, and characterization testing for large molecule therapeutics.
Compensation
Salary Range: $106,000.00 to $138,000.00 . Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits.
Responsibilities
Assist in the development of chromatography, electrophoresis, spectroscopy and mass spectrometry-based analytical methods to be used for product release, stability, and characterization testing.
Contribute to the design and execution of experiments for demonstrating method robustness and performance.
Prioritize and perform timely testing that enables bioprocess and formulation development teams to meet project timelines.
Critically evaluate analytical data to support method development decisions and product quality comparisons.
Maintain accurate and timely experiment records in electronic laboratory notebook (ELN).
Requirements
B.S. or M.S. in Analytical Chemistry, Biochemistry, Chemical Engineering, Pharmaceutical Sciences or related scientific discipline
A Cell Culture Biologist role focused on cell line banking, expansion, cryopreservation, and inventory management within a laboratory environment.
Responsibilities
Generate high-quality cell line stocks to support ongoing research needs, covering the full banking lifecycle including expansion, cryopreservation, record-keeping, storage, and dispensing
Manage multiple suspension, adherent and mixed suspension-adherent cell line cultures simultaneously
Coordinate domestic and international cell line shipments
Maintain accurate record-keeping within the Electronic Laboratory Notebook
Work in a collaborative mass spectrometry laboratory focused on the biochemical characterization of emerging therapeutic modalities and monoclonal antibodies across all stages of development.
Compensation
Salary Range (annually) $93,900.00 - $153,300.00
Responsibilities
Develop and optimize primarily LC-MS-based analytical methods to support diverse R&D programs
Analyze and interpret LC-MS data using appropriate software and bioinformatics tools to characterize the quality attributes of therapeutic proteins and emerging modalities
Support R&D activities and regulatory submissions while expanding organizational knowledge of antibody therapeutics and other emerging modalities
Independently perform sample preparation and LC-MS-based experiments according to SOPs, and document experiments, results, and conclusions in ELN entries
Present data at group and project meetings, and prepare technical reports, SOPs, and regulatory submission documents
The Associate Scientist provides laboratory support in synthesizing salt forms and polymorphs of drug candidates and evaluates these forms for acceptability as drug substances with respect to chemical manufacturing and formulation into pharmaceutical products.
Responsibilities
Conduct solid state characterization (e.g., X-ray powder diffraction, thermal analysis, moisture sorption, microscopy, spectroscopy) of small molecules of pharmaceutical relevance.
Support multidisciplinary project teams and collaborate with colleagues to define and implement crystallization, polymorph, salt, and co-crystal screening activities according to project timelines.
Support multidisciplinary project teams and collaborate with colleagues to define and implement API particle characterization activities according to project timelines.
Conduct physical and surface characterization of powders of pharmaceutical relevance. This includes particle characterization (e.g., particle size, shape) and surface characterization (e.g., surface energy, surface roughness).
Collaborate with colleagues in Medicinal Chemistry, Formulation and Biopharmaceutics to define and implement screening and characterization strategies consistent with solid form selection for clinical studies.
Requirements
Bachelor’s Degree (BS) in pharmaceutical science, chemistry, chemical engineering, or related field
Master’s degree (MS) in pharmaceutical science, chemistry, chemical engineering, or related field
The LIMS Business Analyst will be the face of the LabWare Laboratory Information Management System (LIMS) and Electronic Laboratory Notebook (ELN) at the Charles City Facility, acting as the first level support contact for operational support and Master Data builds.
Responsibilities
Configure and maintain LIMS Master Data to support inventory management, QC/Analytical Research workflows, Raw Material/Intermediate/Finished API testing and release, ELN, cleaning validation and integration with other computerized site systems and instruments.
Provide sound technical subject matter expertise on local and multi-site LIMS Master Data and workflows.
Coordinate LIMS/ELN requirements gathering, fit-gapping, issue root cause identification, solution demos, validation testing, and documentation requirements for the site.
Schedule business meetings and manage escalations to LIMS Development group, applying impact assessments of the current issue list for the facility to support prioritization.
Assist with writing and execution of test scripts for validating LIMS/ELN workflows while maintaining cGDP principles.
Requirements
Bachelor's or Master's Degree in life science or computer science/IT
Nice to have: 3+ years of experience in configuration and administration of LIMS
Scientist Functional GenomicsThe businesses of Merck KGaA, Darmstadt, Germany · Billerica, US
Cell Culture BiologistCogent Scientific · Indianapolis, US
LIMS Business AnalystCambrex · Charles City, US